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EC number: 203-403-1 | CAS number: 106-49-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Original report not available, study on 4-isopropylaniline
Data source
Reference
- Title:
- 4-Isopropylaniline (CAS-No. 88-99-7): Acute oral toxicity test, Combined repeat dose and reproductive/developmental toxicity screening test in rats, Reverse mutation assay in bacteria, Chromosomal aberration test in culturedmammalian cells.
- Author:
- MHW Japan (1999). Ministry of Health and Welfare.
- Year:
- 1 999
- Bibliographic source:
- Toxicity Testing Reports of Environmental Chemicals 7,323-353, 713-716, 726-737, 752-753.
Materials and methods
- Principles of method if other than guideline:
- Migrated dataset. Method: other: OECD Guide-line 422 (see freetext method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 88-99-7
- IUPAC Name:
- 88-99-7
- Reference substance name:
- 4-isopropylaniline
- EC Number:
- 202-797-2
- EC Name:
- 4-isopropylaniline
- Cas Number:
- 99-88-7
- IUPAC Name:
- 4-isopropylaniline
- Details on test material:
- IUCLID4 Test substance: other TS: 4-Isopropylaniline (CAS-No. 88-99-7): Purity: 99.27 %
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- males 48 days; females 15 days before mating, throughout pregnancy until day 3 of lactation
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 6, 20, 60 mg/kg bw/day dissolved in corn oil
Basis:
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Sex: male/female
Duration of test: 54 days
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 60 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 20 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Migrated dataset; Result: see freetext: Result
RS-Freetext:
Results from repeated dose toxicity study part:
1 female was found dead in the 60 mg/kg group at day 25 of gestation.
Anemic eyeballs and salivation were observed in the 20 mg/kg or more groups in both sexes; palor in the 60 mg/kg group was noted in females during gestaion period.
Body weight gain (graphics only) showed a tendency for decrease in the 20 mg/kg or more groups in males and in the 60 mg/kg group in females during gestation period.
Food consumption (graphics only) was decreased in the 60 mg/kg groups in males during the early administration period.
Hematology of males revealed methemoglobin increase in the 20 mg/kg or more groups (1.2 % or 2.5% versus 0.7% in controls)
Furthermore, in the 60 mg/kg male group,
---Decrease:
HCT (40.7% versus 44.7% in controls),
HGB (13.4g/dl versus 15.4 g/dl in controls,
RBC (6.71 x10[exp.6]/mm³ versus 8.21 x10[exp.6]/mm³ in controls)
MCHC (32.9% versus 34.4% in controls)
---Increase:
MCV (60.8µm³ versus 54.5µm³ in controls
MCH (20.0 pg versus 18.7pg)
PLT (1281 x10[exp.6]/mm³ versus 1092 x10[exp.6]/mm³ in controls)
RC (110% versus 28% in controls)
Increases in spleen weights in
- males: in the 60 mg/kg group (absolut/relative): 1.22g/0.683g% versus 0.76g/0.142g% in controls
- females: in the 20 mg/kg or more (absolut/relative):
0.71g/0.231g%, 1.05g/0.351g% versus 0.51g/0.169g% in controls;
Increases in liver weights
- males given 20 mg/kg bw or more (absolut/relative):
15.82g/3.083g%, 16.39g/3.223g% versus 15.12g/2.815g% in controls
- females given 60 mg/kg bw (absolut/relative):
14.43g/4.832g% versus 12.85g/4.285g% in controls
As gross necropsy findings, blackening and enlargement of the spleen were observed in 20 mg/kg or more groups in both sexes.
As histological findings, increases in hematopoiesis in bone marrow, congestion, deposites of pigment and extramedullary hematopoiesis in the spleen were observed in 20 mg/kg or more groups in both sexes. In the liver, extramedullary hematopoiesis was observed in 60 mg/kg males and in the 20 mg/kg or more groups in females. Deposites of pigment and hypertrophy of hepatocytes were observed in both sexes receiving 60 mg/kg bw/day.
NOEL(systemic toxicity male, female): 6 mg/kg bw/day
Results from reproductive and developmental toxicity study part:
As for reproductive ability of parent animals, no adverse effects of the substance were observed in either sex:
with respect to estrous cycle length, copulation index, fertility index, implantation index, gestation index and duration of gestation period, delivery index.
NOEL(parental toxicity): 60 mg/kg bw/day
With regard to the effects on neonates,
no effects on live birth index
no effeccts on sex ratio
60 mg/kg bw-group:
body weight of pups in both sexes decreased (no data)
viability on day 4 of lactation decreased in males:
males: 85.7 % versus 96.4% in controls
females: 97,2% versus 95.1 % in controls
NOEL(developmental toxicity) 20 mg/kg bw/day
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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